Position Summary:
The primary responsibility of the Director of Analytical Services and Formulation (DASF) will oversee and contribute to the analysis and method development of dose formulation for both GLP and non-GLP studies. Analytical Services responsibilities will include analytical method development and sample analysis to be used in support of nonclinical studies, both internal studies and external studies. The Director will supervise the Test Material Formulation group as well.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- The DASF should provide a leadership role in the field of analytical services and formulation to ensure SRC is competitive in the industry and meets market demand.
- Management of staff within test material analytic and dose formulations (Test Material Department – TMD).
- Be proficient in method development for small molecule and biologic test articles.
- Be proficient in all analytical processes.
- Hands on for method development, sample analyses, and test material formulation as needed.
- Ensure that analytical methods and test material formulation are performed according to GLP, when required.
- Maintain competency in GLP regulations and SRC SOPs.
- Work closely and provide support to Study Directors and SRC personnel to resolve analytical issues. The DASF will be required to contribute to Sponsor communication when problem arises with the TMD.
- Work closely with Business Development staff to promote Company analytical capabilities with potential Sponsors.
- Create, administer, and evaluate Analytical Services and Test Material Formulation Training to associates.
- Perform other duties as assigned.
Education and Experience:
- Bachelor’s degree in Analytical Chemistry, Toxicology, Biochemistry, or Pharmaceutical
- science plus 6 years of industry experience
- Master’s degree in related scientific field plus 4 plus years of industry experience, or
- Ph.D. in related scientific field plus 4 years of industry experience.
- Industry experience must include working in a GLP lab within the pharma or contract
- research industry, operating HPLC and working with Toxicology Analytical studies.
Knowledge:
- Expert knowledge of applicable lab techniques.
- Thorough understanding of regulatory policy compliance – specifically GLP.
- Familiarity with current industry trends and expectations.
- Demonstrated proficiency with analytical Dose Formulation Analysis (DFA), method development, validation, and analysis as required by department.
Competencies, Skills & Personal Attributes:
- Strong attention to detail.
- Good written and verbal communication skills.
- Strong technical writing and basic computer skills.
- Willingness and ability to provide procedural training and coaching.
- Ability act in a leadership capacity and mentor others.
- Perform all aspects of job in a way that supports company brand and supports company
- mission, vision and values
